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NAMSA

Month: August 2023

FDA Revised its Final Guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”

On June 2, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices

On August 2, 2023, the U.S. Food and Drug Administration (FDA) published a Federal Register notice that modifications were being made to the Recognized Consensus Standards for Medical Devices database.

FDA Publishes Medical Device User Fees for Fiscal Year 2024

On July 28, 2023, the U.S. Food and Drug Administration (FDA) posted a Federal Register notice announcing the User Fees for Fiscal Year 2024. The fees have increased by 9.5% and will be effective October 1, 2024.